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Published: 16 February 2021

How to build a quality management system for a medical device

Most medical device regulators require medical devices to be designed and manufactured under a Quality Management System (QMS), they also require risk management of the product. So how do you build a QMS? Where do you start?

Our Principal Health Principal, Dr Lee Walsh, design and builds QMS. Watch the video below to learn how to start.

Platypus MedTech Consulting Pty Ltd
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Platypus MedTech Consulting acknowledges that we live and work on the land of the Ngunnawal, Ngambri and Ngarigo peoples, and of the Bidjigal clan of the Eora peoples. We also acknowledge the Traditional Owners of Country throughout Australia where we deliver our services. We recognise the connection of First Nations Australians to land and waters, the sophistication of their knowledge and their contributions to engineering and science, including as Australia's first engineers and scientists. We pay respect to their Elders, engineers, and scientists, both past and present.
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